Phase
Condition
Colic
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Zasocitinib
Clinical Study ID
Ages 18-76 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant is willing and able to understand and fully comply with trialprocedures and requirements (including digital tools and applications), in theopinion of the investigator. The participant has provided informed consent (that is, in writing, documented via asigned and dated informed consent form [ICF]) and any required privacy authorizationprior to the initiation of any trial procedures. Disease-Specific Inclusion Criteria:
Completion of Week 52 in the parent phase 2 CD and UC trials with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001).
Clinical or symptomatic responder at parent trial Week 52 as defined below:
TAK-279-CD-2001: Clinical response in PRO2 at parent trial Week 52, assessed as >=30% decrease in average daily very soft or liquid stools and/ or >=30%decrease in average AP from parent trial baseline.
TAK-279-UC-2001: Symptomatic response at parent trial Week 52, assessed as areduction in partial modified Mayo score (pmMS) of >=1 points and >=30% fromparent trial baseline; and a decrease from parent trial baseline in the rectalbleeding sub-score of >=1 point or an absolute rectal bleeding sub-score of <=1point. Other General Inclusion Criteria:
Participants must meet the contraception recommendations.
Exclusion
Exclusion Criteria:
Participant considered by the investigator to be unsuitable for the OLE trial due totheir trial compliance and medication adherence concerns.
Participants with malignancy or dysplasia per endoscopy any time during the parenttrial or at the beginning of the OLE. Exclusion Criteria related to Laboratory Investigations:
Participants meeting the exclusion criteria related to laboratory investigations asdefined in the protocol. Exclusion criteria related to other prohibited concomitant medication:
Participants taking oral corticosteroids for CD or UC during parent trial at orafter Week 48.
Study Design
Connect with a study center
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesActive - Recruiting

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